DIGITAL BREAST TOMOSYNTHESIS VERSUS DIGITAL MAMMOGRAPHY: A CLINICAL PERFORMANCE STUDY

Abstract: Purpose: To compare the diagnostic accuracy of two-dimensional (2D) full-field digital mammography with that of two-view (mediolateral and craniocaudal) and single-view (mediolateral oblique) tomosynthesis in an observer study involving two institutions. Materials and Methods: Ethical committee approval was obtained. All participating women gave informed consent. Two hundred twenty women (mean age, 56.3; range, 40-80 years) with breast density of 2-4 according to American College of Radiology criteria were recruited between November 2008 and September 2009 and underwent standard treatment plus tomosynthesis with a prototype photon-counting machine. After exclusion criteria were met, this resulted in a final test set of 130 women. Ten accredited readers classified the 130 cases (40 cancers, 24 benign lesions, and 66 normal images) using 2D mammography and two-view tomosynthesis. Another 10 readers reviewed the same cases using 2D mammography but single-view tomosynthesis. The multireader, multicase receiver operating characteristic (ROC) method was applied. The significance of the observed difference in accuracy between 2D mammography and tomosynthesis was calculated. Results: For diagnostic accuracy, 2D mammography performed significantly worse than two-view tomosynthesis (average area under ROC curve [AUC] = 0.772 for 2D, AUC = 0.851 for tomosynthesis, P = .021). Significant differences were found for both masses and microcalcification (P = .037 and .049). The difference in AUC between the two modalities of 20.110 was significant (P = .03) only for the five readers with the least experience (<10 years of reading); with AUC of 20.047 for the five readers with 10 years or more experience (P = .25). No significant difference (P = .79) in reader performance was seen when 2D mammography (average AUC = 0.774) was compared with single-view tomosynthesis (average AUC = 0.775). Conclusion: Two-view tomosynthesis outperforms 2D mammography but only for readers with the least experience. The benefits were seen for both masses and microcalcification. No differences in classification accuracy was seen between and 2D mammography and single-view tomosynthesis.